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Polar Wand Carbon Dioxide Cryotherapy for Barrett's Esophagus

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ClinicalTrials.gov Identifier: NCT01477177
Recruitment Status : Terminated (enrollment much slower than anticipated, and, funding issues)
First Posted : November 22, 2011
Results First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Collaborator:
Chek-Med Systems, Inc.
Information provided by (Responsible Party):
Herbert C. Wolfsen, Mayo Clinic

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Barrett's Esophagus
Intervention Device: Polar Wand carbon dioxide cryotherapy
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Polar Wand Treatment
Hide Arm/Group Description

Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia

Polar Wand carbon dioxide cryotherapy: Patients with Barrett's esophagus dysplasia will be treated with the Polar Wand device at 0 month, 2 and 4 months,6 months (with four quadrant surveillance biopsies), 8 and 10 months (treatment as necessary), and, at 12 months for final surveillance with biopsies throughout entire initial Barrett's segment length.

Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title Polar Wand Treatment
Hide Arm/Group Description

Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia

Polar Wand carbon dioxide cryotherapy: Patients with Barrett's esophagus dysplasia will be treated with the Polar Wand device at 0 month, 2 and 4 months,6 months (with four quadrant surveillance biopsies), 8 and 10 months (treatment as necessary), and, at 12 months for final surveillance with biopsies throughout entire initial Barrett's segment length.

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
66
(61 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
0
   0.0%
Male
4
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
4
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification
Hide Description The reduction of Barrett's segment length and histology classification will be measured at 12 months.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated study. Enrollment much slower than anticipated and funding issues.
Arm/Group Title Polar Wand Treatment
Hide Arm/Group Description:

Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia

Polar Wand carbon dioxide cryotherapy: Patients with Barrett's esophagus dysplasia will be treated with the Polar Wand device at 0 month, 2 and 4 months,6 months (with four quadrant surveillance biopsies), 8 and 10 months (treatment as necessary), and, at 12 months for final surveillance with biopsies throughout entire initial Barrett's segment length.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Reduction in Barrett's Segment Length, Using the Prague Classification
Hide Description [Not Specified]
Time Frame 6 and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated study. Enrollment much slower than anticipated and funding issues.
Arm/Group Title Polar Wand Treatment
Hide Arm/Group Description:

Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia

Polar Wand carbon dioxide cryotherapy: Patients with Barrett's esophagus dysplasia will be treated with the Polar Wand device at 0 month, 2 and 4 months,6 months (with four quadrant surveillance biopsies), 8 and 10 months (treatment as necessary), and, at 12 months for final surveillance with biopsies throughout entire initial Barrett's segment length.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Assessment of Complications
Hide Description Specific complications are GI Bleeding and Perforation and Stricture and Ulceration
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated Study. Enrollment much slower than anticipated and funding issues
Arm/Group Title Polar Wand Treatment
Hide Arm/Group Description:

Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia

Polar Wand carbon dioxide cryotherapy: Patients with Barrett's esophagus dysplasia will be treated with the Polar Wand device at 0 month, 2 and 4 months,6 months (with four quadrant surveillance biopsies), 8 and 10 months (treatment as necessary), and, at 12 months for final surveillance with biopsies throughout entire initial Barrett's segment length.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Assessment of Post-ablation Symptoms
Hide Description Specific symptoms (frequency and severity) are chest pain, difficulty swallowing, painful swallowing, nausea or vomiting, sore throat
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated Study. Enrollment much slower than anticipated and funding issues.
Arm/Group Title Polar Wand Treatment
Hide Arm/Group Description:

Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia

Polar Wand carbon dioxide cryotherapy: Patients with Barrett's esophagus dysplasia will be treated with the Polar Wand device at 0 month, 2 and 4 months,6 months (with four quadrant surveillance biopsies), 8 and 10 months (treatment as necessary), and, at 12 months for final surveillance with biopsies throughout entire initial Barrett's segment length.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Reduction in Barrett's Histology Grade, Using the Modified Vienna Classification
Hide Description The reduction of Barrett's segment length and histology classification will be measured at 6 months.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Terminated Study. Enrollment much slower than anticipated and funding issues.
Arm/Group Title Polar Wand Treatment
Hide Arm/Group Description:

Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia

Polar Wand carbon dioxide cryotherapy: Patients with Barrett's esophagus dysplasia will be treated with the Polar Wand device at 0 month, 2 and 4 months,6 months (with four quadrant surveillance biopsies), 8 and 10 months (treatment as necessary), and, at 12 months for final surveillance with biopsies throughout entire initial Barrett's segment length.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse Events were collected for 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Polar Wand Treatment
Hide Arm/Group Description

Cryotherapy device utilizing carbon dioxide (room temperature gas) for treatment of GI neoplasia

Polar Wand carbon dioxide cryotherapy: Patients with Barrett's esophagus dysplasia will be treated with the Polar Wand device at 0 month, 2 and 4 months,6 months (with four quadrant surveillance biopsies), 8 and 10 months (treatment as necessary), and, at 12 months for final surveillance with biopsies throughout entire initial Barrett's segment length.

All-Cause Mortality
Polar Wand Treatment
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Polar Wand Treatment
Affected / at Risk (%)
Total   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Polar Wand Treatment
Affected / at Risk (%)
Total   0/4 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Herbert C. Wolfsen, M.D.
Organization: Mayo Clinic
Phone: 904-953-6319
EMail: Wolfsen.Herbert@mayo.edu
Layout table for additonal information
Responsible Party: Herbert C. Wolfsen, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01477177     History of Changes
Other Study ID Numbers: 11-004237
First Submitted: October 24, 2011
First Posted: November 22, 2011
Results First Submitted: April 23, 2019
Results First Posted: May 15, 2019
Last Update Posted: May 15, 2019